[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635528":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":53,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":26,"enrollmentInfo":64,"targetDuration":26,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":26,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional Radiology guided embolization\u002Fretrograde tranvenous obliteration of shunt","ACTIVE_COMPARATOR","Embolization of the porto-systemic shunt will be conducted via Trans-Jugular, Trans-Femoral, or direct Trans-hepatic access to embolize the shunt using cyanoacrylate glue, Sodium TetraDecyl Sulfate, Gelfoam, and\u002For vascular coil injection. The procedure will be performed under deep sedation or general anesthesia, with fluoroscopic guidance and intraprocedural antibiotic prophylaxis.",[13],"Procedure: Interventional Radiology for shunt embolization\u002Fretrograde tranvenous obliteration",{"label":15,"type":16,"description":17,"interventionNames":18},"Endoscopic ultrasound guided embolization of shunt","EXPERIMENTAL","Embolization of the porto-systemic shunt will be performed via endoscopic ultrasound (EUS) transesophageal or transgastric access with a 19G fine-needle aspiration (FNA) EUS needle to embolize the shunt using cyanoacrylate glue and vascular coil injection. The procedure will be performed under general anesthesia, with fluoroscopic guidance and intraprocedural antibiotic prophylaxis.",[19],"Procedure: Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts","Coils are deployed at identifiable angulated points and in sequential manner until there a cessation of flow in SPSS on doppler monitoring; glue is then injected counter to blood flow and upstream (i.e. towards spleen) from the coils to maximize intraluminal polymerization and reduce risk of embolization. Size and number of coils will vary on a case by case basis according to the size of the SPSS, and coils with a size of at least 25% larger than the size of the SPSS will be used as standard sizing. Coils will be inserted using a 19 gauge fine needle via an endoscopic ultrasound through an either transgastric\u002Ftransduodenal approach.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Interventional Radiology for shunt embolization\u002Fretrograde tranvenous obliteration","Interventional Radiology (IR) embolization of a splenorenal shunt (specifically Spontaneous Splenorenal Shunts - SPSS) is a minimally invasive procedure, often using Balloon-Occluded Retrograde Transvenous Obliteration (BRTO) or coils, to treat severe, refractory hepatic encephalopathy caused by blood bypassing the liver. It forces blood back through the liver, improving function, but carries risks of increased portal pressure, ascites, or worsened varices.",[9],[32],{"facility":33,"status":26,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Rutgers University Hospital","Newark","New Jersey","07103","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-74.17237,40.73566,{"lat":43,"lon":42},[46,51],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Kaveh Hajifathalian, MD","CONTACT","973-972-9814","kh852@njms.rutgers.edu",{"name":47,"role":52,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":52,"investigatorFullName":47,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Program Director, Advanced Endoscopy","100635528","endoscopic-shunts-embolization-for-refractory-hepatic-encephalopathy-100635528",false,"NCT07553858","Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy","Endoscopic Ultrasound Embolization of Porto-Systemic Shunt for Management of Medically Refractory Hepatic Encephalopathy: A Randomized Trial","Inclusion Criteria:\n\n1. Adults aged ≥18 years with known cirrhosis\n2. MRHE; defined as ≥2 episodes of hepatic encephalopathy, HE (as documented in an outpatient office visit or during an inpatient admission) within 6 months prior to enrollment despite medical therapy with lactulose and rifaximin\n3. Admission to inpatient hepatology floor at University Hospital-Newark with MRHE at the time of enrollment\n4. Presence of a spontaneous portosystemic shunt; confirmed on CT\u002FMRI at the index admission.\n\nExclusion Criteria:\n\n1. Severe\u002Frefractory ascites defined as ascites that does not recede after medical therapy or reoccurs shortly after fluid has been removed\n2. Refractory or recurrent bleeding from esophageal varices\n3. Presence of portal vein thrombosis with complete occlusion\n4. Hepatocellular carcinoma beyond Milan criteria or other advanced malignancy with limited life expectancy (\\\u003C6 months)\n5. Platelet count of less than 35,000 and\u002For INR of more than 2 which cannot be corrected for the EUS guided embolization procedure.\n6. Hepatic venous occlusion, or right heart failure as the etiology of cirrhosis.","ALL","18 Years",{"count":65,"type":66},34,"ESTIMATED","INTERVENTIONAL",[69],"NA","The goal of this clinical trial is to learn if endoscopic ultrasound guided (EUS guided) spontaneous porto-systemic shunt (SPSS) embolization works to treat refractory hepatic encephalopathy in adults. It will also learn about the safety of EUS guided embolization. The main questions it aims to answer are:\n\n1. Does EUS guided embolization maintain an acceptable safety profile?\n2. Does EUS guided embolization of large SPSS result in significant clinical improvement in patients with refractory hepatic encephalopathy?\n\nParticipants will:\n\n1. Receive EUS guided embolization or medical management.\n2. Receive follow-up EUS procedures one month after embolization for assessment of the shunt patency and development of varices (embolization group).\n3. Receive follow-up every week for 4 weeks to assess degree of worst episode of hepatic encephalopathy via West Haven criteria.",[72,73,74],"Hepatic Encephalopathy","Liver Cirrhosis","Portal Shunt Systemic","NOT_YET_RECRUITING","2026-04-20",{"date":78,"type":79},"2026-04-28","ACTUAL",{"date":81,"type":66},"2026-05-01",{"date":83,"type":66},"2028-11-01",{"name":5,"class":6},1]